This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

MannKind's Diabetes Device Under More Clouds

VALENCIA, Calif. (TheStreet) -- Common sense went AWOL during MannKind's (MNKD) conference call Tuesday morning.

MannKind officials, including billionaire inventor and CEO Al Mann, spent an hour on the phone with investors, trying to put a positive spin on Monday's decision by the U.S. Food and Drug Administration to delay approval of Afrezza, the company's inhaled insulin device for diabetes.

Yet, the more Mann and his underlings spoke, the more confusing and nonsensical the call became. Doubts and questions about the approvability and commercial viability of MannKind's Afrezza device seem more pronounced today than they were Monday.

MannKind's shares closed Monday at $7.89 but rose about 12% in Tuesday's pre-market trading session in advance of the conference call. By the call's conclusion around 10 am, the stock sunk into the red, down 4% to $7.57 in recent trading.

In January, MannKind said FDA was forced to delay the approval decision for Afrezza because the agency has mistakenly forgot to complete an inspection of the European facility that makes the insulin used in Afrezza.

Yet on Tuesday's call, MannKind admitted that the FDA inspection of that insulin plant was still not complete and was scheduled for next week. Management couldn't explain how or why FDA chose issue to its complete response letter for Afrezza on Friday with the manufacturing plant inspection still outstanding.

MannKind management confirmed FDA is questioning the "clinical utility" of Afrezza. The company is required to submit data to FDA showing how Afrezza is to be used, by which diabetes patients in particular, and when the device's use is best.

MannKind insists that no new clinical trials will be needed to compile this information for FDA, yet the company acknowledges that its original data package containing this type of information was not robust enough to assuage the FDA's concerns.

Under questioning, the company also admitted that one reason FDA wants additional data on Afrezza's clinical utility is because Afrezza's use, if it's ever approved, will be restricted to certain types of diabetes patients.

The FDA has told MannKind that Afrezza will require a risk-management plan to better inform patients of the risks of the device. This might include a requirement that doctors test the lung function of patients using Afrezza, according to MannKind's 10-K filed with the Securities and Exchange Commission.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,083.80 -2.83 -0.02%
S&P 500 1,987.98 +0.97 0.05%
NASDAQ 4,472.1080 -1.5890 -0.04%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs